E-DRUG: Proposed Drug Regulatory Authority Pakistan: Just an eye wash
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Dear E-Drug members,
The Federal Government in Pakistan has announced establishment of an autonomous Drug Regulatory Authority (DRA) ostensibly to ensure supply of quality medicines to people and streamlining registration process. The proposal has come at a time when the Ministry of Health is under fire from the Supreme Court for unchecked proliferation of spurious and adulterated drugs in the country as well as issues related with unethical marketing and prices of medicines. The draft of a new DRA Act soon to be presented in the Parliament, raises new fears and questions.
The existing statute, Drug Act 1976 and the rules made there under, offers necessary legal provisions and implementation mechanisms to solve issues like spurious and counterfeit medicines, unaffordable prices, unethical marketing leading to irrational use of medicines, etc which are presently plaguing the sector. However, most of the law has never been implemented in the 30 years of its existence allowing the situation to deteriorate in the pharmaceutical sector to one of total lawlessness. One wonders what is the justification to bring a new regulatory framework in the presence of an adequate existing Drug Act of 1976? What magic potion is added to the new law to solve the pressing problems of the sector?
We would request other E-Druggers to also look into the draft law and the proposal of the DRA and share their views on it. The drafts of the DRA framework and Act are available from these links:
http://www.dcomoh.gov.pk/downloads/DRA-Framework-16Feb.doc?PHPSESSID=14cd256ee7fd5630aeb4429b2cd991d3
and
http://www.dcomoh.gov.pk/downloads/DRA-ACT-2006.doc?PHPSESSID=14cd256ee7fd5630aeb4429b2cd991d3
[repair links]
We have the following concerns with the new development:
The problem in pharma sector in Pakistan has been that of implementation of the law, not lack of it. The proposed DRA Act to be brought on top of the existing law will worsen the problem even further.
The autonomy of the Authority is questionable as the federal government will maintain direct executive control on it. Besides, a technical authority as the DRA is, is proposed to be lead by a non-technical ex-civil servant, and advised by smart market boys, can only result into the very obvious leeway for the vested interest.
Instead of providing any measures to improve regulation, the proposed draft is loosening regulation particularly on quality assurance and prices which is a big issue already.
TheNetworks detailed critique on the proposed framework and the Act is available at our website: www.thenetwork.org.pk. The issue needs to be addressed and discussed at the broader level and we will appreciate if any such experiences in other countries, both successes and failures, are shared.
Regards
Tauqeer Mustafa
TAUQEER MUSTAFA CHOUDHRY.
Project Officer
(Health and Pharmaceuticals)
The Network for Consumer Protection
40-A, Ramzan Plaza, G-9 Markaz
Islamabad, Pakistan
Ph# Off: 92-42-2261085
Hand Ph# 92-333-4101610
tauqeermustafa@yahoo.com